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Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing - The INSTAR study
EU CTIS ID: 2024-515350-25-01
What this study is testing
The primary objective is to determine the efficacy of systemic corticosteroids in preventing recurrent wheezing and asthma in first-time severely wheezing children with rhinovirus infection, stratified by rhinovirus genome load.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- All of the following conditions must apply to the prospective patient prior to receiving study agent: 1) age 3-24 months, 2) first acute severe wheezing episode, defined as first-time acute breathing difficulty with wheezing ever, appearing less than 7 days from onset of symptoms, in a child referred to hospital, and with one or more of a) fever, b) hypoxia (SAT O2 ≤ 92%), c) retractions (inter-, subcostal), d) prolonged expiration (on auscultation), e) expiratory rhonchi (on auscultation), 3) evidence of rhinovirus infection by PCR test in nasopharyngeal secrete, 4) signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
You likely can't join if
- Patients will be excluded from the study if they meet any of the following criteria: 1) previous episodes with wheezing, defined as a history of acute breathing difficulty with wheezing in need of treatment at a general practitioner or at hospital, or parental information about similar breathing difficulties, 2) gestational age <37 weeks, 3) chronic illness other than atopy (eczema), 4) previous systemic or inhaled corticosteroid treatment, 5) COVID-19 related disease, 6) participation to another trial, 7) varicella infection or contact during the last 2-3 weeks, 8) need for intensive care unit treatment during the present infection, except for non-invasive respiratory support with high flow nasal cannula ventilation, CPAP or BIPAP, 9) any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.